Medical Device Application

Application Change history

Application Progress Date

Date received:

Review Information

Review flag:

Auto review required :

Device Product Characteristics

Application Summary

Application ID:

Submission ID:

Sponsor's own reference:

Application for:

Class llb Status : Approved

18/03/2005

No

DV-20050317-DA-001392-2

DV-2005-1100

PROLIFT Pelvic Floor Repair System

Will you be applying for listing O Yes O No of this product or procedure in the Medicare Benefit Schedule (MBS)?

Will you be applying for listing O Yes O No of this product on the Prosthesis List?

Will you be applying for listing O Yes O No of this product on the Co-dependent or hybrid technology application list?

Sponsor name: Johnson & Johnson Medical Pty Ltd

Sponsor ID: 267

Agent name:

Contact details :

Contact email :

ARTG No : 117686

Manufacturer Information

Manufacturer's evidence:

Manufacturer name:

Assessment route:

Assessment body:

GMDN code:

GMDN description:

Intended purpose :

Device Category Terms

Device category 1:

Attached Documentation

History

0211 26-WEBE-5G8UM2 : Ethicon Sarl#2 Goto !

Ethicon SARL Switzerland (Switzerland) [32135)

Council Directive 93/42/EEC (MOD) Counci l Directive 93/42/EEC (MOD)

TUV SUD Product Service GmbH [0123)

Mesh kit[45034]

A collection of mesh, typically pre-cut, and various instruments (e.g., guide, cannula) used to implant mesh during a surgical procedure (e.g. , repair of the pelvic floor).

Total, Anterior and Posterior pelvic floor repair system for tissue reinforcement and long-lasting stabil isation of fascial structures of the pelvic floor in vaginal wall prolapse.

Single use devices

30/03/2005 12:26:04 PM Approved.

Review Completed - Accepted, 30/03/2005)

Recor d

Fee:

Start Dates

Date

670 Date Paid: 23/03/2005

Date 30/03/2005 Decision:

Finish Dates Working Days

Application Received

18/03/200 Payment Received 23/03/200 3 5 5

Payment Received 23/03/200 Application 5 Decision

30/03/200 5

Total Working

Days

8

11

Medical Device Application

Application Change history

Application Progress Date

Date received:

Review Information

Review flag:

Auto review required:

ARTG & Product ID

ARTGID

Product ID

Application Details

Application identifier:

Submission identifier:

Sponsor's own reference:

Application for:

Class llb Status : Approved

18/03/2005

No

117686

198079

DV-20050317-DA-001392-2

DV-2005-1100

PROLIFT Pelvic Floor Repair System

Will you be applying for listing O Yes O No of this product or procedure in the Medicare Benefit Schedule (MBS)?

Will you be applying for listing O Yes O No of this product on the Prosthesis List?

Wi ll you be applying for listing O Yes O No of this product on the Co-dependent or hybrid technology application list?

Cancel ARTG - product:

Sponsor Details

Sponsor name:

Contact details:

Contact email:

Class Details

Class: Class llb

Intended purpose: Total, Anterior and Posterior pelvic floor repair system for tissue reinforcement and long-lasting stabilisation of fascia! structures of the pelvic floor in vaginal wall prolapse.

Device Product Characteristics

Is the device, or any form of the device, supplied sterile: Yes

Sterilisation Method:

Is the device intended to be invasive: Yes

s the device, or any form of the device, intended for single use: Yes

Is the device an active device: No

Does the device contain material or ingredients of microbial origin: No

Does the device contain material or ingredients of recombinant origin: No

Does the device contain material or ingredients manufactured or No formulated using a genetically modified organism:

Does the device contain material or ingredients of Human Origin: No

Does the device contain Human Blood or its components: No

Does the device consist of: Products packaged as a system

Does the device contain material or ingredients of Animal Origin rendered No non-viable

Animal Species:

Country of Origin:

Does any component in the procedure, kit or system contain material or No ingredients of Animal Origin rendered non-viable:

Is the device medicated: No

Is the device formulated: No

Does the product contain a medicine that is supplied separately in the No Australian Market:

Does the product contain a medical device which incorporates a medicine No as an integral part and that has an action ancillary to the device:

Does the device contain a metal on metal bearing:

I declare that this device contains only components that are medical No devices which have been individually certified.

Manufacturer Details

Manufacturer evidence number:

021126-WEBE-5G8UM2 : Ethicon Sari #2

Manufacturer name:

Manufacturer address as on evidence:

GMDNS Code and Description

Ethicon SARL Switzerland (Switzerland)[32135]

RUE OU PUITS GODET 20 NEUCHATEL CH-2000 Switzerland S[ 91416] RUE OU PUITS GODET 20 NEUCHATEL CH-2000 Switzerland S[ 91416]

GMDNS code and description: Mesh kit[45034]

Device Category Terms

Device category 1 :

Device category 2:

Device category 3:

Product Details

UPI (Unique product identifier) :

Total number of devices covered:

Functional decription:

Variant List

#

Device system name if applicable:

Standard Conditions

Non Standard Conditions

Note: A non standard conditions must not contain semi colons.

Declaration

Single use devices

Variant type

(a) devices of the kind in question are medical devices; and

Variant range

To remove, enter item#

(b) devices of that kind are intended for a specified purpose, as ascertained under The definition of a medical device; and

(c) (d) (e)

the kind of device is correctly classified according to the medical device classifications; and devices of that kind comply with the essential principles; and I:

(i) have available sufficient information to substantiate that compliance with the essential principles; or

(ii) have procedures in place, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and (f) an appropriate conformity assessment procedure has been applied to devices of that kind; and (g) I:

(i) have available sufficient information to substantiate the application of those conformity assessment procedures; or

(ii) have procedures in place, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and (h) devices of that kind comply with every requirement (if any) relating to advertising applicable under the regulations; and (i) devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901 ; and (ia) devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41 BEA; and (j) the information included in or with the application is complete and correct.

I understand the consequences of making a false declaration, as outlined below.

In electronically submitting this application to TGA, I hereby declare that in relation to this medical device the information given in this application and the above statements on this declaration form are current and correct.

PLEASE NOTE: A false declaration will result in the device entry being removed/cancelled from the ARTG.

Signatory name of the person submitting the application. :

History

30/03/2005 12:26:04 PM Approved.

Review Completed - Accepted, 30/03/2005)

Record Date Fee 670IDate Paid

!Date Decision

23/03/2005

30/03/2005

Start Dates Finish Dates Working Days Application Received 18/03/2005 jPayment Received 23/03/20051 3 Payment Received 23/03/2005 jApplication Decision 30/03/20051 8

Total Working Days 11